Study of Impact of Not Measuring Residual Gastric Volume on Nosocomial Pneumonia Rates

NCT01137487 | Completed DMC

• 1 other identifier: NUTRIREA1
• Study Type: interventional
• Target: 452
• Locations: 1 country
• Sites: 6

Brief Summary

Early enteral feeding is a key component of the management of critically ill patients receiving mechanical ventilation. However, enteral feeding has been associated with serious complications such as aspiration followed by ventilator-associated pneumonia (VAP). Many critically ill patients experience poor tolerance of early enteral nutrition because of impaired gastric motility, which leads to a sequence of delayed gastric emptying, increased gastric volume, gastroesophageal reflux, vomiting, aspiration, and VAP. Routine monitoring of residual gastric volume (RGV) to minimize the risk of aspiration is standard practice. RGV is assumed to reflect gastric content, with high RGVs indicating impaired gastric emptying that requires discontinuation of enteral feeding in order to prevent aspiration.However, RGV measurement is neither standardized nor validated. The cut-off value that may indicate an increased risk of aspiration and therefore a need for discontinuing enteral feeding has not been determined, and cut-offs used in studies have ranged from 150 to 500 ml. No data are available to support a correlation between RGV and the rates of adverse events. In experimental studies, RGV failed to correlate with vomiting, aspiration, or VAP. The investigators hypothesize that RGV monitoring fails to decrease the risk of VAP and leed to inappropriate interruptions in enteral feeding with a risk of underfeeding. To assess the effects of not measuring RGV on VAP and enteral feeding delivery, the investigators designed a prospective randomized controlled study.

Conditions

Ventilation-Associated Pneumonia

Keywords

mechanical ventilation; enteral nutrition; Ventilation-Associated Pneumonia; residual gastric volume measurement; vomiting; gastro-oesophageal reflux; early enteral nutrition; Intensive care unit; Enteral Feeding

Outcome Measures

Primary Outcomes (1)

• To compare ventilator associated pneumonia rates in patients receiving early enteral feeding without residual gastric volume (RGV) monitoring and in patients with RGV monitoring

  until weaning of mechanical ventilation (average : 14 days)

Secondary Outcomes (2)

• mortality rate

  60 days

• vomiting rates

  until weaning of mechanical ventilation (average : 14 days)

Study Arms (2)

residual gastric volume

OTHER

Procedure: monitoring of residual gastric volume

residual gastric volume not monitored

OTHER

Procedure: not monitoring of residual gastric volume

Interventions

monitoring of residual gastric volume PROCEDURE

measurements of residual gastric volume every six hours in patients receiving early enteral feeding and mechanical ventilation

Also known as: Residual Gastric Volume Measurement

residual gastric volume

not monitoring of residual gastric volume PROCEDURE

no measurements of residual gastric volume

Also known as: Non residual Gastric Measurement

residual gastric volume not monitored

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Treatment with invasive mechanical ventilation
• Feeding via nasogastric tube within 36 hours after the initiation of endotracheal mechanical ventilation.
• Age over 18 years
• Informed consent

You may not qualify if:

• Mechanical ventilation started more than 36 hours before institution of enteral feeding
• History of esophageal or gastric surgery
• EN via a gastrostomy or a jejunostomy
• Bleeding from esophagus, stomach or bowel
• Moribund patient
• Age less than 18 years
• Pregnancy.
• No informed consent.

Sponsors & Collaborators

• Centre Hospitalier Departemental Vendee: lead
• University Hospital, Tours: collaborator

Study Sites (6)

CH Angoulème - Réanimation Polyvalente

Angoulême, France

Location

CHD Vendée - Service de Réanimation

La Roche-sur-Yon, 85000, France

Location

CHU Limoges - Réanimation Polyvalente

Limoges, France

Location

CHU Orléans - Réanimation Médicale

Orléans, France

Location

CHU Poitier - Réanimation Médicale

Poitiers, France

Location

CHU Tours - Réanimation Polyvalente

Tours, France

Location

Related Publications (1)

• Reignier J, Mercier E, Le Gouge A, Boulain T, Desachy A, Bellec F, Clavel M, Frat JP, Plantefeve G, Quenot JP, Lascarrou JB; Clinical Research in Intensive Care and Sepsis (CRICS) Group. Effect of not monitoring residual gastric volume on risk of ventilator-associated pneumonia in adults receiving mechanical ventilation and early enteral feeding: a randomized controlled trial. JAMA. 2013 Jan 16;309(3):249-56. doi: 10.1001/jama.2012.196377.

  PMID: 23321763 DERIVED

MeSH Terms

Conditions

Vomiting; Gastroesophageal Reflux

Condition Hierarchy (Ancestors)

Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Esophageal Motility Disorders; Deglutition Disorders; Esophageal Diseases; Gastrointestinal Diseases; Digestive System Diseases

Study Officials

• Jean REIGNIER, MD, PhD

  CHD Vendée

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 19, 2010
• First Posted: June 4, 2010
• Study Start: May 1, 2010
• Primary Completion: June 1, 2011
• Study Completion: August 1, 2011
• Last Updated: March 1, 2013

Record last verified: 2013-02

Locations

FR (6)